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Chamber and committees

Meeting date: Tuesday, December 5, 2017

Meeting of the Parliament 05 December 2017

Agenda: Time for Reflection, Urgent Question, Topical Question Time, Planning and Inclusive Growth, Polypropylene Mesh Medical Devices, Urgent Question, Decision Time, Neurological Conditions (Sue Ryder Report)


Contents


Polypropylene Mesh Medical Devices

The Deputy Presiding Officer (Linda Fabiani)

The next item of business is a debate on motion S5M-09241, in the name of Johann Lamont, on petition PE1517, on polypropylene mesh medical devices. I call Johann Lamont to speak to and move the motion on behalf of the Public Petitions Committee.

15:10  

Johann Lamont (Glasgow) (Lab)

I am pleased and privileged to open the debate on behalf of the Public Petitions Committee and to play a small part in the opportunity to bring this critical issue to further public attention. Petition PE1517, on polypropylene mesh medical devices, was lodged in April 2014, receiving more than 1,700 signatures of support and attracting 212 comments. The committee will consider a draft report on the petition in due course and it will reflect on this debate in its deliberations. What is said today will help to shape that important report.

Before I move on to the key themes and concerns raised by the petition, I would like to place on record my thanks, on behalf of the committee, to the petitioners, Elaine Holmes and Olive Mcllroy, and all the other women and their husbands, partners, friends and families who have provided their testimony on the impact that mesh has had on their lives. That testimony was often given at huge personal cost. Although, through their courage, we have been given a window into what they have suffered, we do not live with the daily impact of mesh on every aspect of our lives. The testimony is set out in the 80-plus written submissions that we have received on the petition to date. It would be remiss of me not to acknowledge the members who do not sit on the committee but who have joined us in our consideration of the petition. I expect that Jackson Carlaw, Neil Findlay, Alex Neil and John Scott will contribute to the debate, just as they have contributed to the committee’s deliberations.

The session 4 committee’s consideration of the petition started in June 2014 with evidence from the petitioners. It is an indication of the impact of the evidence that just two weeks later, Alex Neil, then the Cabinet Secretary for Health and Wellbeing, gave evidence to the committee. It was in the course of that evidence session that the intention to establish an independent review and the request for a moratorium on the use of mesh devices were announced. It is worth reflecting on that moratorium, as it transpired that mesh operations continued while that was in place.

We heard during our most recent evidence session from Dr Wael Agur that the cabinet secretary’s request was disseminated to health boards by the chief medical officer. The request asked the boards to consider suspending the use of mesh in procedures for pelvic organ prolapse or stress urinary incontinence. However, it became clear that boards retained autonomy over their operations and, as such, were under not under a binding obligation to act upon the request or to confirm whether it was intended that mesh procedures would continue in their area. Although I cannot speak for the members of the session 4 committee, that would not have been their understanding of what a moratorium should entail. That should be reflected on in any future circumstances in which a moratorium may be requested. I would welcome a commitment from the cabinet secretary to ensure that that is done.

With that said, members will understand that I wish to focus most of my opening remarks on the process and outcomes of the independent review. The review group comprised urologists, researchers, public health professionals, patient representatives and representatives of professional bodies, the regulatory body for medical devices and the office of the chief medical officer. Secretariat support to the chair was provided by the Scottish Government. The independent review’s published remit was:

“to evaluate both the efficacy and the extent and causes of adverse incidents and complication rates associated with SUI and for POP”.

Its formal title was the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women.

At our most recent meeting, the petitioners informed the committee that they had to fight to get the word “safety” put in the heading of the review. That certainly gave me pause for thought, as I am sure it did for other committee members.

The independent review group got to work and reached a milestone when it published an interim report in October 2015. Its interim report was tentatively welcomed, in so far as it represented signs of progress and enabled interested parties—not least the Government and mesh survivors—to reflect on the interim conclusions.

It should be noted, however, that the petitioners produced a minority report and that the Scottish mesh survivors group considered that the recommendations should be actioned immediately and that outcomes should be monitored before any further mesh procedures took place.

The interim report produced eight conclusions. They related to the need for robust clinical governance; the need for multidisciplinary team working, with appropriate levels of audit activity to ensure the recording and reporting of adverse events; and the need to ensure that women have the opportunity to discuss with their clinician all the options that are available to them, and the pros and cons of each, so that they can give fully informed consent. There was a “serious concern” that some women who had reported adverse events were not believed. There were concerns about the efficacy of short-term studies of the safety and effectiveness of mesh procedures, given that many adverse effects do not become evident until five, 10 or more years after a mesh procedure.

There were also concerns about the lack of reliable or robust information systems to record the number of procedures that are carried out and, by extension, difficulties in accurately measuring adverse events. There were other concerns around the use of transobturator mesh procedures, rather than retropubic mesh tape procedures, for what was referred to as “routine surgery” for stress urinary incontinence; those concerns were based on information that was produced in chapter 6 of the interim report and accompanied by a number of tables. Similar concerns were expressed in the report about the use of mesh in surgery for pelvic organ prolapse.

It was explained that the October 2015 report was interim because the independent review was awaiting the outcomes and findings from two key pieces of work. The first of those was the final opinion of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks on the safety of surgical meshes used in urogynaecological surgery, which was published in December 2015. Its recommendations included that

“Implantation of any mesh for the treatment of POP via the vaginal route should only be considered in complex cases, in particular, after failed primary repair surgery”,

and that

“The amount of mesh should be limited for all procedures where possible.”

The second piece of work was the “Prolapse Surgery: Pragmatic Evaluation and Randomised Controlled Trials” study, which is referred to as the PROSPECT study. One of the primary outcomes to be assessed in that three-year study was the quality of life for women who had reported prolapse symptoms. Its final report was published in The Lancet in December 2016. It concluded that

“augmentation of a vaginal repair with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects or any other outcome in the short term”.

In addition, it found that more than 1 in 10 women—approximately 12 per cent—experienced a complication associated with mesh. The study concluded that follow-up was “vital” to identify whether there were any potential longer-term benefits for women and, conversely, to identify any potential serious adverse effects of mesh procedures for pelvic organ prolapse.

With those two pieces of work completed, the independent review’s final report was published in March this year. It would be a significant understatement to say that the final report was not as well received as the interim report. There were resignations from the independent review group shortly before publication of the final report, amid reported concerns that it was not fully independent, was misleading and was a backwards step from the interim report. Indeed, the petitioners were reported by the BBC as feeling “betrayed” and concerned that the report was “a whitewash”. Concerns were expressed by the petitioners and members of this Parliament that information had been either omitted altogether or moved to a different part of the report.

Significant concerns related in particular to the removal from the final report of the tables on shared decisions in chapter 6. Those concerns have already been raised in this chamber, both at topical questions and during the cabinet secretary’s statement to the Parliament on 30 March.

In May, the committee took evidence from the chair of the independent review and then from the cabinet secretary and the chief medical officer. It was unfortunate that the evidence that we heard seemed to produce more questions than answers. We were unable to establish a clear understanding of how decisions were taken in the independent review. We could not establish whether decisions were taken by sub-groups, the full group or at the discretion of the chair. The committee thought that that lack of clarity could have been avoided through the provision of readily accessible minutes or notes of correspondence.

There was also confusion about the timeline of communications between the petitioners, the cabinet secretary and the chair of the independent review, which extended to decisions that were made following receipt of the petitioners’ communications asking for the removal of all their contributions from the report, which did not happen.

The review’s final report recommends the mandatory reporting of mesh adverse events. That is welcome, although it appears from the evidence that we heard that that conclusion was reached quite late in the day. A number of other recommendations are also welcome, in so far as they address systems and practices that should be in place as a matter of clinical governance.

I want to focus on two recommendations. First, the recommendation in conclusion 7 of the final report, which relates to stress urinary incontinence, is:

“women must be offered all appropriate treatments (mesh and nonmesh) as well as the information to make informed choices.”

I cannot stress how important it is that when women are considering their options they have the opportunity to discuss them with their clinician and have their views listened to. Discussions must be based on the most up-to-date information available.

Conclusion 8, on the surgical treatment of pelvic organ prolapse, is that a mesh procedure does not provide “any additional benefit” over natural tissue repair. However, that conclusion seems somewhat qualified by the next sentence, which is:

“Transvaginal mesh procedures must not be offered routinely.”

I emphasise the word “routinely”.

In evidence to the committee, the cabinet secretary advised that the Scottish Government would establish an oversight group to take forward the recommendations. She added:

“the key safeguards that are to be put in place ... must be implemented before any procedures using mesh are reintroduced routinely”.—[Official Report, Public Petitions Committee, 18 May 2017; c 24.]

When I sought clarification from the cabinet secretary on whether the moratorium would remain in place until the recommendations have been implemented, she replied that the suspension would not be lifted until medical directors have assured the chief medical officer that all the recommendations in the final report have been implemented.

It could be argued that much of what the petition called for has been delivered. For example, a moratorium was put in place, an independent review was initiated, reporting of adverse events will be mandatory, and progress is being made towards fully informed consent. However, the outcome of the independent review is such that it would be absolutely inappropriate for the petition to be closed at this point.

That is reflected in the fact that the cabinet secretary has commissioned Professor Alison Britton to conduct a review of the independent review. Along with the deputy convener of the committee, I have had the opportunity to meet Professor Britton, to explore her remit and flag up to her some of the concerns and issues that have come to light in recent months as part of our consideration of the petition.

The cabinet secretary has offered her reassurance that the recommendations of the independent review’s final report stand, pending the conclusion of Professor Britton’s review of the review. However, the overriding concern that has come across during our consideration is people’s lack of confidence in the independent review process and therefore in its outcomes. Given people’s already fragile confidence in the independent review’s governance and findings, if Professor Britton’s review finds that the process was significantly flawed, how can the cabinet secretary, this Parliament and, most important, the public be assured that the independent review’s outcomes are robust and credible? I hope that today’s debate provides an opportunity for that question and others to be answered.

We might, sadly, have to confront the harsh truth that the damage that was done to the petitioners and others cannot be repaired, but we must do what we can to ensure that their experience is not repeated. Believing all those women and responding to their well-founded understanding of what must change would be a good start. [Applause.]

I move,

That the Parliament notes public petition PE1517 on polypropylene mesh medical devices.

The Deputy Presiding Officer

I respectfully say to people in the public gallery that it is not appropriate to show appreciation—or otherwise—during the debate. Thank you.

15:24  

The Cabinet Secretary for Health and Sport (Shona Robison)

I am grateful for the opportunity to take part in today’s debate on what is a very important issue and for the chance to give the Parliament an update on the Scottish Government’s work in this area. I want to thank the Public Petitions Committee for all its work and deliberations on the issue of transvaginal mesh. Most important of all, I thank Elaine Holmes and Olive McIlroy, who brought the issue to light through their petition.

Members might recall that I made a statement on transvaginal mesh back in March. At the time, I spoke about what had led my predecessor to establish the Scottish independent review of mesh—the brave action of the Scottish mesh survivors, who were patients who had suffered serious complications and had petitioned the Parliament. In doing so, they spoke very openly about the difficulties that they faced on a daily basis. Indeed, it is those actions, as well as the stories that I have heard from women who have written or spoken to me over the months and years, that have led me to continue to treat the issue with the utmost importance.

Given the complexity of the issue, it has proved difficult to reach a consensus. However, what is important is how we move forward and that the improvements that we propose allow us to keep our aim of continuous improvement in NHS Scotland.

Members will recall my commitment to look at concerns that had been raised about the process of the independent review. That is why I asked Professor Alison Britton of Glasgow Caledonian University to examine the course of the independent review. She will produce a report with recommendations about how future similar reviews could be conducted.

Neil Findlay (Lothian) (Lab)

The concerns were about much more than the process. Is it not an issue that the women—who feel, quite rightly, that no one was listening—have had to go through the very long petitions process to get to the stage that we are at today?

Shona Robison

Neil Findlay makes an important point. It should not have taken a petition for the issue to be brought out into the light. However, some important changes have flowed from that, which I want to highlight. It is important to record the fact that changes have been made. We must not lose sight of the central issue, which is that we must continue our work to address the issues that have been raised by so many women and to build on the work of everyone who has taken part in the independent review and the process that Neil Findlay referred to.

The review made eight clear key recommendations. The Scottish Government has accepted all of them, and it expects all health boards to take note of future developments, as I will now explain. Officials have been working with the General Medical Council to draft updated guidance on shared decision making, which Johann Lamont made an important point about. The drafting of that updated guidance is now complete and it will be subject to wider consultation, which, it is anticipated, will start in the spring of next year. The emphasis of the guidance is on sharing information, explaining risk and giving choices. The importance of doctors working in partnership with patients and supporting them to make decisions is stressed, and all clinicians are expected to abide by that.

When I made my statement in the chamber in March, I explained that an oversight group would be established. That group is absolutely key, and I can confirm that Healthcare Improvement Scotland has taken forward that work in the months since I made the announcement. The oversight group will regularly review data relating to mesh procedures and will scrutinise adverse event reporting. What is particularly significant is that it will continuously review new studies and new evidence, and will carefully consider how that new evidence can be incorporated into pathways of care. The group will also help to ensure that patient information is relevant and up to date. Indeed, producing a patient information and consent leaflet for pelvic organ prolapse and reviewing the existing leaflet for stress urinary incontinence will be key tasks for the group.

It is important that the oversight group has on board the right people, who have the level of expertise and experience that is necessary to take forward such critical work. That is why I am pleased to be able to confirm that Professor Lorna McKee has been appointed chair of the oversight group. Professor McKee is now emeritus professor of management and health services research at the University of Aberdeen. I wish her well in her role and look forward to receiving future updates on the progress that is being made in achieving implementation of the review group’s recommendations.

Neil Findlay

The cabinet secretary mentioned the University of Aberdeen. I do not know the individual involved, but is the Government aware of any allegations of research misconduct on the SIMS study that was carried out in Aberdeen? Has there been any communication between the Government and those who were involved in that study?

Shona Robison

I make it very clear that Professor McKee is absolutely above reproach in the matter. It is very important that she is allowed to get on with the job of chairing the oversight group. I hope that there is no inference from Neil Findlay that she is in any way connected with that study; those issues are completely separate. We should allow her to get on with the important work of the oversight group.

Healthcare Improvement Scotland has well-established procedures for engaging with the general public, through its public partners scheme. HIS will ensure that the oversight group has full representation for patients who have direct experience, in the best way that they feel they wish to be involved. The group will meet for the first time in early December, when it will focus on future planning. The first full meeting of the group will take place in January.

John Scott (Ayr) (Con)

Will the cabinet secretary take an intervention?

Shona Robison

I would like to make some progress, if the member does not mind.

As my colleagues will be aware, there was an almost parallel process in NHS England, involving a different group of patients, clinicians and evidence reviewers, which, in July this year, published a report that came to very similar conclusions. However, I wish it to be noted that, in Scotland, the independent review went further and used the language of the regulator—the GMC—stating that mesh procedures

“must not be offered routinely”

for POP, whereas the NHS England report noted that

“The use of vaginal mesh in primary procedures to treat POP is not supported by the current evidence and this should not be offered routinely for the first surgical intervention”.

Members will be aware that the National Institute for Health and Care Excellence will shortly publish its updated guidance on the use of mesh for pelvic organ repair, as part of its interventional procedures programme guidance. As NHS Scotland is a full partner in that programme, the guidance must—and will—be implemented. Such procedures will be included in patient management pathways and, as I have mentioned, the new evidence for those pathways will be overseen by the new oversight group. I await the revised guidance with interest; however, what we already have in place in Scotland is a clear set of recommendations that place a clear emphasis on patient safety.

I can confirm that the chief medical officer for Scotland has today written to all NHS board medical directors and to the oversight group, drawing their attention to the forthcoming NICE guidance. The CMO has also written to the Medicines and Healthcare Products Regulatory Agency, which after all—as we have discussed many times in the chamber—is the only organisation that can ban mesh. The CMO has pointed to a recent publication by the Australian Therapeutic Goods Administration, and it is important that we hear back from the MHRA about its response to that publication.

I want to be clear, meanwhile, that the request to suspend remains in place, and will do so until the CMO is satisfied that all the recommendations have been implemented, including all upcoming changes to guidance, and that necessary safeguards are in place. In essence, we expect that the consent procedures and other safeguards will be put in place, taking into account all new guidance into pathways, meaning that the situation in future will not be greatly different from that under the current suspension. What we all want to see is a change in the whole approach to the condition.

I hope that, over the last few minutes, I have been able to set out the updated position—

John Scott

Will the cabinet secretary take my intervention before she closes?

Shona Robison

I will do so in my closing remarks, because I am in my last few seconds.

The Deputy Presiding Officer

I can allow the cabinet secretary the time to do so.

Shona Robison

I hope that I have been able to give members reassurance that the Scottish Government takes the issue very seriously, and that we have made progress since the publication of the independent review report. In my closing remarks, I will come back to members on any other issues that they might want to raise.

15:33  

Jackson Carlaw (Eastwood) (Con)

This full debate, brought to the chamber by the Public Petitions Committee, is long overdue and especially welcome.

It is now nearly some four years since my constituent, Elaine Holmes, visited my constituency office, on crutches; she was anxious about the nature of what she had to discuss and share, but absolutely determined, even then, that she would do all she could to bring a spotlight to mesh procedures and to what has gradually, but inexorably, become a worldwide scandal and in Scotland a devastating tragedy for far too many women.

I do not say “scandal” lightly. Having been born in 1959, I remember my bewildered shock when, as a child in the mid-to-late 1960s, I read newspaper features in The Sunday Times on thalidomide. That, too, was marketed as a convenience for women—and a safe one at that. Facts were concealed, lives have been ruined and compromised to this day, and women have been patronised by experts living, practising, operating, researching and preaching from their ivory towers. Mesh is the 21st century’s thalidomide: it is a worldwide scandal that is every bit as devastating.

At the heart of the mesh scandal is the most deeply personal testimony. Who expects to find themselves, without warning, suffering from chronic pain and a loss of sexual function, with mesh protruding through the bladder or bowel—sometimes removed, with horrendous consequences—and with organs trapped and entwined with mesh, shrinking and moving inside the body, and slicing through nerve endings, tissue and those same organs? I have met the women in wheelchairs and on crutches, and who among us cannot appreciate their courage in stepping forward to discuss such intimate details with, in many cases, male politicians?

The Public Petitions Committee led. Alex Neil, as Cabinet Secretary for Health and Wellbeing, led. No one doubted the commitment, too, of Shona Robison, as the review committee established in 2014 went about its business. That is why the sense of betrayal and dismay among all those mesh survivors is so profoundly felt. They thought, I thought—frankly, we all thought—that the Government was on their side. The rest of the world took note. As litigation that has now generated billions in compensation commenced, here was political leadership in Scotland, where the unique circumstance of a smaller national health service made action possible and credible. We were ahead of the rest of the United Kingdom. Due to the many health boards and the lack of co-ordinated patient networks, England was slow to pull everything together. Patients there, too, looked to Scotland.

Throughout, I have listened to many experts, including those who appeared before the Public Petitions Committee. In a risible and dismal performance here at Holyrood, so-called experts, the lamentable MHRA, denied that there was even an issue or that many women were affected, even as those women sat in packed rows behind them. Other experts dared to suggest that women might seek psychiatric help.

Surely the most reasoned and impressive of all those experts was the consultant physician Dr Wael Agur, who is also a constituent of mine. Along with Elaine Holmes and Olive McIlroy, he resigned from the review committee in abject dismay and professional fury at the bowdlerisation of the committee’s draft report—including the travesty of chapter 6—into the shameful and widely despised whitewash of the final report.

The new chair was a deeply unimpressive witness. It was Dr Agur who spoke without artifice and with sincere clarity. As he talked through his journey towards believing in a complete ban, he exposed the fallacy of the informed consent process. Of the 22 women who made use of his health board’s shared decision-making tool to assess whether mesh was appropriate for them, only one—yes, just one—decided in favour of the procedure, and that was because she had not read the leaflet properly. When she did, she changed her view.

I understand and take note of what the cabinet secretary said about the advice and guidance that are under way and which will be subject to scrutiny, and I look forward to seeing the outcome of that.

There was talk ahead of the debate of amendments to the motion to make a much more direct demand of Government. I understand those calls, but I am not yet convinced that the moment has arrived when this Parliament must divide. However, I want to be very clear with the cabinet secretary: this is last chance saloon territory. If decisive progress is not forthcoming, we will, however reluctantly, seek to find common cause with others in this chamber to require and mandate action and change. As the SNP MP Brendan O’Hara stated in the Westminster Hall debate in October,

“this devastation for women and their families is absolutely intolerable and must never be allowed to happen again”.—[Official Report, House of Commons, 18 October 2017; Vol 629, c 296WH.]

There must be no interruption to the current ban. There must be a full public consultation on the content of the review that took place, to be published alongside the procedural review led by Professor Britton. There must be sustained engagement with the Westminster Government in respect of the actions and performance of the MHRA. Politicians on all sides will willingly join in that, here and at Westminster, where Owen Smith MP and my East Renfrewshire colleague Paul Masterton MP respectively chair and co-chair the all-party group on mesh. The Scottish Government must act on Alex Neil’s proposal to convene an international summit here at Holyrood to allow Scotland to regain the political initiative.

There may be aspects of this scandal that are reserved and other aspects that are devolved, but for pity’s sake that can no longer be a defence against the most determined and joint close working and co-operation.

The hourglass has run. Huge legal compensation claims the world over are landing with health services; more than 800 claims are under way in the UK. That, too, is an issue of immense concern.

However, this issue is about more than money, consent and all the most basic issues of a woman’s dignity, and her quality of life and that of her family, and that too of the increasing number of men who have had mesh implanted and have experienced complications. Led by Elaine Holmes and Olive McIlroy, these Scottish women are an inspiration. I will confess to being a sentimental sort, but the coldest glass eye could not be in the company of those women, who, compromised in so many ways, have become a joint support network, a hugely entertaining social party and one of Scotland’s most effective campaigning groups, and not be moved by their efforts.

I want Scotland to lead again. I want us to prevent mesh from destroying more lives. In all sincerity, I want this Parliament to be able to look to our Government to regain that leadership. We have waited patiently as due process has promised hope, only to thwart it instead. I look to the Government for justice and say to the cabinet secretary, “Please act, and please act now.”

15:40  

Neil Findlay (Lothian) (Lab)

I thank the Public Petitions Committee for bringing the debate to the chamber. It has been a long time coming.

Five years ago, on becoming my party’s shadow cabinet secretary for health, I was handed a portfolio of issues by my colleague Jackie Baillie. In it were a few news cuttings about an issue that no one was really talking about—transvaginal mesh implants. Along with Tommy Kane, my researcher, I soon met the then small group of women who had been affected by the product. We immediately struck up a friendship that has been sustained to this day. They are some of the finest people I have ever met, and I am proud to call them my pals.

All of them have been affected by the polypropylene product that was permanently inserted into their bodies in an attempt to address incontinence or prolapse. When mesh is implanted, body tissue grows through its pores, so it cannot be removed without serious nerve and tissue damage; removal has been compared to removing chewing gum from a person’s hair. In many patients, the mesh lost its pliability, became rigid and started to break up, dispersing shards and fragments throughout the body.

The past five years of the campaign have been very emotional. Let me tell you why. It is because women—young, middle-aged and older—were told by surgeons and health boards, many of whom had a conflict of interests, that they would be treated by a short procedure that was the new “gold standard” in care, and that after it, all would be well.

Was it “well”? If we call lacerated and ruptured organs “well”; if we call a severed urethra “well”; if we call being forced to use crutches or a wheelchair for the rest of your days “well”; if we call the loss of a kidney, the end of a person’s career, the loss or their sex life, the end of their relationship or marriage, and the loss of their house and life savings “well”; and if we call mental ill health “well”, then yes—all is well.

The reality is that tens of thousands of women around the world are living with chronic physical and mental pain and a lifetime of hopes and dreams lost, and are forced to struggle against the might of the medical establishment and the cosy relationship between the big medical companies including Boston Scientific and Johnson & Johnson, surgeons, health boards, Governments and the MHRA, all of which denied that there was a problem and told women that they were imagining things or exaggerating.

Month in and month out, my office staff and I worked with the Scottish mesh survivors group, which is led brilliantly by Elaine Holmes and Olive McIlroy. We took them to meet Alex Neil, the then Cabinet Secretary for Health and Wellbeing, and asked him to ban mesh. At that time, he said that he could not because he feared being sued by the manufacturers. After numerous freedom of information requests, parliamentary questions and much lobbying, we found ourselves coming up against a brick wall, so we advised the women to lodge their petition. I will never forget the day when it was presented to the Public Petitions Committee. Dozens of sobbing women sat hugging and supporting each other in solidarity on what David Stewart, who was then convener of the committee, said was one of the most emotional days of his political career.

The petition forced Alex Neil to suspend the use of mesh, but not before yet more women had been implanted. We then forced the establishment of the so-called independent review, on which Elaine and Olive sat. It met at least 10 times and unanimously agreed an interim report. Then the chair resigned, a new chair came in and no meetings took place for the next 10 months. Well, actually, they did take place—but Elaine and Olive were not told about them and no minutes were circulated. With the new chair in place, the final report was radically changed from the interim report, to the extent that Elaine, Olive and Dr Agur could not sign up to it, and they all resigned.

At that point we met the new Cabinet Secretary for Health and Sport and asked her to ensure that the mesh survivors’ contributions were withdrawn from the report before publication. We were assured that that would happen, only for the report to be published with no changes, which was a shocking breach of faith. In the run up to that event, more than 100 MSPs from across parties signed a “No mesh whitewash” pledge. The Scottish mesh survivors group’s view is that the report is a whitewash—a deep, big and murky barrel of it.

On the review were four surgeons—doctors Karen Guerrero, Voula Granitsiotis and Wael Agur, and Mr Paul Hilton—three of whom are subject to litigation by mesh survivors. None of them declared that conflict of interests before taking part in the review.

Mr Paul Hilton is one of the main witnesses for the NHS Scotland Central Legal Office in the forthcoming civil action for damages that has been brought by 420 patients. His position—and the position of the other doctors—on mesh was predetermined before he took part in the review.

Mr Hilton also failed to declare that his wife—

The Deputy Presiding Officer

I will stop you there, Mr Findlay. I ask you to bear in mind that those matters may be sub judice.

Neil Findlay

I sought clarification on the matter from the chief executive of the Parliament.

Mr Hilton also failed to declare that his wife, Dr Lucia Dolan, is also subject to litigation in Scotland.

After all that, does the cabinet secretary still believe that the review is independent? Will she allow the report to go out for public comment, as Jackson Carlaw has suggested? Will she agree to the indefinite suspension of mesh? Will she tell the NHS to clear its shelves of mesh, so that it can no longer be used. She has the powers to do that. Will she use her procurement powers to end its purchase? Will she write to the medical companies urging them to settle the litigation cases quickly and to stop their deliberate stalling? Will she instruct a judge-led inquiry, similar to the baby ashes inquiry, into what is the biggest multiple litigation in the history of Scotland’s NHS?

Scotland had the opportunity to lead the world on mesh: everyone was watching, and we flunked it. The review was compromised from the outset. The Government has let down mesh victims. This is a tragic tale of corporate power and greed, institutional arrogance by the medical establishment, and Government ambivalence and delay. It is only because we have refused to give up that we have got this far. I say to the cabinet secretary that we are not going away. This is the Government’s last chance to make radical changes, or we will introduce political motions that seek to unite the Opposition on the issue.

The Deputy Presiding Officer

We move to open debate. I ask for speeches of about six minutes. I have a bit of time in hand, so I can allow for interventions.

15:47  

Alex Neil (Airdrie and Shotts) (SNP)

I, too, pay tribute to the work of Elaine Holmes and Olive McIlroy and all the mesh survivors. Their campaign has been absolutely fantastic, well motivated and very effective. I pay tribute to the Public Petitions Committee—in particular, the convener, Johann Lamont, and the deputy convener, Angus MacDonald, who have done an excellent job so far on the petition, although there is still a way to go.

I also pay tribute to the late Chrissy Brajcic, a Canadian campaigner who died last week of sepsis. She was in the process of suing Ethicon over her treatment and was part of the Canadian mesh survivors group. This is not just a Scottish issue; it is a worldwide issue. I thank Jackson Carlaw for reiterating my call for the Public Petitions Committee, with the support of the full Parliament, to call an international conference to take co-ordinated action against the real culprits: the manufacturers of the mesh equipment that has been neither properly tested nor trialled before it was introduced worldwide.

I hope that Parliament can unite on the matter. This is not about the Opposition against the Government. I think that we all share concerns, and I think that we all need and want to do what is right by the survivors, and to prevent such a situation happening again.

I am going to be open, honest and very transparent. It took me longer to commission the independent inquiry that I might have taken. Why? It was because, to be quite frank, I was—very unusually—not convinced by the information on the matter with which I was provided by official advisers when I was health secretary. On no other matter did I have any reason for doubt, but I increasingly felt that I was not being told the truth, the whole truth and nothing but the truth. I ended up doing a lot of research into the subject myself . The more I researched, the more I became convinced that we had to do something: at the very least, we had to suspend the procedures until we were much more sure about their safety. I am glad that we did that.

Neil Findlay

Will Alex Neil take an intervention?

Alex Neil

I will, if Neil Findlay will make the intervention brief.

Neil Findlay

Were the people who advised Alex Neil the same people who are now advising the cabinet secretary?

Alex Neil

I have no idea. For the record, I was absolutely clear when we appointed members of the independent review group that none of them should have a commercial interest in mesh. That did not happen; I am very critical of that.

John Scott

In Alex Neil’s time as cabinet secretary, did he assess potential contingent liabilities in damages due to the Scottish survivors of the mesh implants from the class actions elsewhere in the world.

Alex Neil

We were aware of potential legal proceedings in Scotland, the rest of the United Kingdom and the rest of the world. That was a consideration for my research—rather than relying entirely on the official advice—which reinforced my view that there was something seriously wrong that had to be addressed.

Members have quite rightly addressed the independent review procedure and the very good interim report, which was unanimously agreed. Something happened, however, between the interim report and the final report. In between those two reports, more research came out, but it was never taken into account in the final report. I agree with Jackson Carlaw that one of the best witnesses at the Public Petitions Committee, apart from the women who were the best witnesses, was Dr Agur, who explained why he resigned as a member of the group. As well as reviewing the report process, we need to review the report contents, which are so disrespected. To be frank, there is not universal agreement that we should accept the contents, as they stand.

Fortunately, as the cabinet secretary has outlined, we have made advances. A decision has been made in Australia to which we should listen and learn from. There are also NICE and GMC guidelines available, which we will need to police to ensure that they are adhered to well. However, that will not be enough; we need to do other things. I welcome the cabinet secretary’s comments about the establishment of the oversight group, but proper oversight in this case needs patient involvement. A drawback in the whole review procedure has been that patients and survivors feel that they have not been listened to. Such oversight would not second guess or undermine the role of medics; clearly, those of us who are not trained cannot exercise medical judgment. However, patients—particularly the survivors—have a lot of potential input into what to look for in an oversight arrangement. Health Improvement Scotland uses lay members in most of its inspections; we should involve patients in the oversight procedure.

I have mentioned the current state of the leaflets, and I will write separately to the cabinet secretary about their details. There is a clear commitment from her to ensure that the leaflets are up to date and easily accessible and readable.

I have three other points to make quickly. First, there should be an onus on any surgeon who has commercial involvement with the producer of a product that he or she uses on a patient to tell the patient about that commercial interest.

Secondly, it is very clear that the MHRA is not fit for purpose. It is partly funded by the mesh manufacturers, so I do not see how it can be truly independent.

Thirdly, we must ensure that any future independent review is genuinely independent. I look forward to Professor Britton’s report. We can never again have such processes tainted by suspicion such as surrounds the outcome of the review.

If we implement those suggestions and those that other members have made—and, no doubt, suggestions that are yet to come—we will, I hope, get the right answer. We will also ensure that no other woman—or, indeed, man; some men have suffered—need suffer what the women who have been affected have had to suffer and will, in some cases, endure for the rest of their lives. [Applause.]

The Deputy Presiding Officer

I remind people in the public gallery that neither appreciation nor otherwise should be shown.

15:56  

Brian Whittle (South Scotland) (Con)

I refer members to my entry in the register of interests, as I have a close family member who is a healthcare professional in the NHS.

I welcome the opportunity to speak in the debate. The issue has been on the Public Petitions Committee agenda since before my arrival in the Parliament and it has delivered some of the most harrowing of the evidence-taking sessions in which I have been involved in my short time here. It has certainly focused my mind on the fact that, amid all the white noise of political debate, what we do in the Parliament has a profound effect on the lives of people in Scotland. In this case, the topic has a far wider reach than, and has implications beyond, our borders. It is not overstating the importance of the debate to suggest that the eyes of other nations are watching to see how the Parliament deals with the continuing issue of polypropylene mesh implants.

The sight of the cabinet secretary and the chief medical officer being cross-examined in committee by current and former committee members, with so many women who have been affected by the procedure sitting behind them, many in wheelchairs, was vivid. It was uncomfortable to watch and listen to that evidence while seeing the reaction from those who sat behind the cabinet secretary—they seemed aghast. The fact that the current committee members were joined by Jackson Carlaw, Alex Neil, John Scott and Neil Findlay highlights the cross-party strength of feeling and support for the campaign. It also highlights the need for the Parliament to come together and end the scandal.

To that end, I add my sincere gratitude to the members of the Scottish mesh survivors hear our voice campaign for their unrelenting and resolute campaigning to try to ensure that what they have had to endure will be spoken about in the public forum and that no one else need have their lives devastated by the potential repercussions of the procedure. The campaign also highlights the national and international impact that a public campaign can have through the Public Petitions Committee.

However, there are questions to be answered. First, how is it that a former health secretary, in the shape of Alex Neil, can take the robust action of imposing a moratorium on the use of transvaginal mesh only for certain health boards to continue to use the procedure to treat stress urinary incontinence, with some 400 women undergoing the procedure since the moratorium was introduced? Who should have ensured that the moratorium was adhered to? With whom does the responsibility lie? Why do we set rules if there is no system to enforce them? It was news to me—and many other MSPs, apparently, as well as the campaigners—that a moratorium that the Government calls for is not binding. That must be a matter of concern and the Parliament must address it. Had the moratorium held in the manner in which I believe it was intended to, we would not be in the position in which we find ourselves today.

Worse than that is the debacle of the initial review and the resignations from the review panel amid allegations of the changing of language and the omission of key evidence and findings from the review. Ultimately, there seems to be clear evidence of an attempt to whitewash the issue. Although we are not trying to be party political, I have to say that the response from the Government and the cabinet secretary in particular has been, at best, sluggish and indecisive. With such a weight of evidence piled against the procedure, action could and should have been clear cut by now. It was obvious to all that all was not well within the review panel.

The involvement of the MHRA, as already mentioned, has been absolutely shocking. A body in which we place a great deal of trust and responsibility has been exposed as inadequate and incapable of applying any degree of logic or care, with experts claiming that sufferers’ pain could be psychosomatic. At no point has there been a duty of care or candour, and it was painful watching the new chair of the review board squirm in her seat under questioning during an evidence session, as her answers caused gasps from the women seated behind her. A lack of empathy and understanding was all too evident, and I have to agree with my colleague Jackson Carlaw in his assertion that there must be a full public consultation on the content of the review that took place. I also want consideration given to Alex Neil’s proposal to convene an international summit here at Holyrood to allow Scotland once again to lead the way.

Putting an end to this procedure is well overdue. The ban must remain in its entirety, in the way that was originally intended. That must surely be a precursor to an end to this operation for good. I once again thank the petitioners for their courage and persistence, and I close by assuring them that their voices are now certainly being heard.

16:01  

Rona Mackay (Strathkelvin and Bearsden) (SNP)

Today’s very important debate is one that I wish was not happening, because the circumstances surrounding it are shocking and upsetting, particularly for the thousands of women whose lives have been devastated by transvaginal mesh implants. This is not, or should not be, a political issue, as others have said. Since long before I was elected, colleagues from across the chamber, particularly the former health secretary Alex Neil, Neil Findlay, Alison Johnstone, John Scott, Jackson Carlaw and others, have fought tirelessly to help women affected by this issue.

I say that it should not be political because the mesh survivors watching this debate could not care less about party politics. They are simply searching for answers, asking why this has happened to them and why a surgical procedure that was supposed to help them has ruined their lives.

My former colleague, journalist Marion Scott, who has spearheaded the campaign from day 1, along with mesh survivors Elaine Holmes and Olive Mcllroy, did not get involved because it was a good story, despite displaying the highest standard of investigative journalism, which is all too often sadly lacking these days. Marion has supported mesh sufferers because their pain and distress is all too visible. Their quest for justice despite their suffering was and is relentless, and they deserve our full praise and admiration. However, mesh sufferers are not looking for praise. Olive Mcllroy and Elaine Holmes do not want television cameras in their living rooms; they want answers.

Before they knew each other, Olive and Elaine were trying to cope with the crippling aftereffects of surgery that they had been told would change their lives. Both had been told they were unique. They were not. We now know that thousands of women worldwide have been affected—mothers, daughters, sisters, aunts and grans. The mesh survivors are not campaigning for themselves. They are not doing it for money. They are doing it so that no more women have to suffer as they have—lives ruined, families shattered.

I vividly remember seeing on TV in 2014 the joy and delight on the faces of the women, led by Marion Scott, at the committee meeting as the suspension on mesh implants, introduced by Alex Neil, was announced. However, as I understand it, since the suspension at least 400 women have had a mesh tape implant to treat the very common condition of stress urinary incontinence. Incidentally, if anyone does not know what the tape implant looks or feels like, they should imagine the strong plastic tape that binds a bale of newspapers—the kind of tape that cuts your finger if you touch it in the wrong way. That is what women are dealing with when it is put inside their bodies.

Like everyone else in the chamber, I do not pretend to be a medical expert, but what I do know is that when clinicians cannot agree—as we heard in Elaine Smith’s powerful members’ business debate on thyroid diagnosis and treatment a couple of weeks ago—it is the patient who suffers. As with the thyroid problem, the vast majority of mesh sufferers are women. I leave people to draw their own conclusions on that.

The Scottish Government cannot ban the use of medical procedures, but it can ask health boards to suspend their use, which is what was done. As a result of the petition, some progress has been made, albeit slowly, such as the stipulation that mesh should not be offered routinely to women and that all patients must have access to clear, understandable advice to help them make an informed choice. All appropriate treatments should be made available, subject to informed choice. A helpline has been established. Reporting of all procedures and adverse effects will be mandatory. As we have heard, a new oversight group is being set up to ensure that the conclusions are implemented, so there is progress. We are at last heading in the right direction.

It is, however, the UK body—the MHRA—that decides what medical products are safe. We must now put complete pressure on the MHRA, which has been in denial over this issue from day one. We should ask what more proof it needs that the product is not safe and show it the victims. We should tell the MHRA to tell health boards that the product is not available for use.

Of course, there are clinical risks with every surgical procedure and side effects to all medicine taken, but when hundreds of women are so severely affected, the risk must surely be too great and we must stop doing it.

As a member of the Public Petitions Committee, I am well aware of the serious issues that the report into the review and the review of the review threw up. Time does not allow me to delve into it and other members have outlined the issue very well. However, when those in authority, in whatever field, stop listening to the people at the centre of the issue, the people they are supposed to protect, it is a disaster.

The Scottish mesh survivors hear our voice campaign is an outstanding tribute to the courage and determination of the women who are determined to effect change. Those in power must start hearing their voice, albeit belatedly, before more women’s lives are destroyed.

16:06  

Monica Lennon (Central Scotland) (Lab)

I am grateful for the opportunity to speak in today’s debate. I add my appreciation to the Public Petitions Committee for its work thus far on this important petition.

Most of all, I am grateful for the incredible bravery and strength of mesh survivors in Scotland, whose tenacity in campaigning to raise awareness of the issue has led us to the point that we are at today. Like all members, I am totally in awe of the strength and passion of the women I have met who are part of the Scottish mesh survivors group.

Earlier this year, I joined parliamentary colleagues at a meeting with the Scottish mesh survivors that was organised by my colleague Neil Findlay, who has been a long-time champion of the voices of mesh survivors, and who has done some excellent work in raising awareness of these women, as have several other members of the Scottish Parliament from various parties.

Nothing can prepare us for the stories of these women. I can only imagine the pain that they have had to endure over the years. However, I share their rage that this has been allowed to happen to them. All the Scottish mesh survivors, ordinary women who have ordinary lives, have had those lives turned upside down by the implantation of transvaginal mesh.

Intended to address incontinence or pelvic prolapse, the insertion of polypropylene mesh was, for many of these women, a procedure that they had been led to believe was first-class, safe and would make their lives better. For so many of the women who have undergone those procedures, that could not have been further from the truth.

As we now know, in many patients, the mesh began to break up, dispersing fragments throughout the women’s bodies and causing incredible damage. Some of the women I met earlier this year told me about ruined relationships and careers, the daily struggle of living with chronic pain, the loss of the full use of their legs, and the unbelievable pain of having to deal with how those changes utterly changed their lives, shattering hopes and dreams for the future.

The implantation of mesh in women across Scotland on the NHS is a national scandal. The way in which those women have been denied, first by their doctors when they first expressed their concerns—they were told that they were imagining or exaggerating their symptoms—then by the medical companies, and now by Governments that are tasked with investigating the whole debacle, is nothing short of an outrage.

During the drive to get MSPs to sign up to the say no to mesh whitewash pledge earlier this year, one of the women I met told me about her experience when she first started having problems following mesh surgery. Her surgeon repeatedly told her that she was a unique case and the only one he had ever known to experience adverse side effects. For months, she was none the wiser. It was only through her discovery of the mesh survivors group and discussion with other women who had gone through the surgery, some with the same surgeon, that she discovered that that doctor had been telling several other women the same thing. It is an absolute outrage that the health of those women has been put so terribly at risk by that procedure. Not only is the implantation of mesh unsafe, some practitioners and medical companies who advocate its use have clearly known about the dangers and have been complicit in misleading women about the effects.

Earlier this year, a few of us launched the cross-party group on women’s health; I am the convener and Alison Johnstone MSP is the vice convener. The purpose of the cross-party group is:

“To inform Parliament and policymakers on a range of health issues which only, predominantly or disproportionately affect women; to consider the impact which gender and inequalities has on women’s health and their ability to access healthcare and treatment and to empower women to make informed choices about their health and ensure they are treated with dignity and respect.”

In large part, the discussions that I was having with a range of groups as my party’s inequalities spokesperson sparked the need for this cross-party group to be established, and the experience of the women from the mesh survivors group absolutely played a role in the desire for these women’s health issues to be looked at more closely.

The way in which so many of these women have been brushed off and disbelieved is outrageous; it should never be allowed to happen again. These women deserve justice, so I echo the call of my colleague Neil Findlay that the mesh scandal must be investigated with a judge-led inquiry that is truly independent of the health service and the Scottish Government. I urge the health secretary to give that call serious consideration.

As an MSP who was elected in 2016, I am fairly new to the parliamentary scrutiny of mesh and I am struggling to understand how health boards were able to disregard the moratorium and get away with it without any apparent consequence. I ask the cabinet secretary to give an answer on that in closing.

Mesh survivors in Scotland and across the world have been silenced and sidelined for too long. It is beyond time that their concerns were investigated seriously through a truly independent inquiry, and that the calls of their petition were considered by the Scottish Government. I ask the cabinet secretary to give her whole-hearted commitment to that in closing.

16:12  

Alison Johnstone (Lothian) (Green)

I, too, thank members of the Public Petitions Committee for their work on this critical issue, MSP colleagues who have supported the women, and—most of all—the mesh survivors themselves, who have campaigned to make the risks of mesh surgery clear, to have the procedures suspended in Scotland, and to protect other patients from harm.

Meeting the mesh survivors when they came to Parliament was eye opening. They are women of different ages and backgrounds who have gained great strength from coming together and realising that, as Monica Lennon has just pointed out, they are not alone and are not unique—unfortunately. I came into a room packed with women who are reliant on wheelchairs and crutches. What chronic condition or illness was responsible for these life-limiting symptoms? Surgery, here in Scotland.

I spoke to women who had worked in high-level roles in justice and in care—in services that we all rely on—who are no longer able to make a living and are reliant on others for help and support. No one appreciates more than the women themselves how debilitating and how life-restricting incontinence can be. Although we all appreciate that surgery can never be guaranteed 100 per cent safe or side-effect free, for a group of patients to have such high hopes of life-improving surgery only to have such devastating outcomes is absolutely unacceptable.

What is clear is that the consent that was given to surgeons by these determined and remarkable women was far from informed. That is why their work and campaigning are so important. Incontinence is an issue affecting millions, yet it is rarely discussed in public. The mesh survivors have ensured that that will change.

I will never forget meeting one of the survivors, who attended with her husband. They explained how their relationship had been changed forever by this procedure. Imagine your partner going to hospital for surgery to treat incontinence and that resulting in their facing the rest of their life in a wheelchair, with their incontinence considerably worsened, their autonomy and self-esteem shattered, and physical intimacy a fading memory. I met a woman in tears because she was no longer able to lift up her beloved grandchildren.

When we discussed with survivors the issue of reversing or rectifying the surgery, I, like Neil Findlay, heard that they had been told that removing mesh could be likened to removing chewing gum from hair.

I appreciate the forthright evidence that Elaine Holmes and Olive McIlroy presented to the Public Petitions Committee in September and the detailed account that Dr Agur gave of his involvement with the independent review. He noted key differences between the interim report and the final published report. Dr Agur firmly believes that the final report did not do enough to reduce harm and was too ambiguous about the risks of mesh surgery, contrary to the evidence that analyses the long-term adverse effects of mesh surgery, including mesh erosion and chronic pain.

From Dr Agur’s evidence, it is clear to me that, at one point, the work that was led by the independent review group made it

“The first authority in the world to formally express concerns about a procedure that many clinicians and surgeons and other authorities around the world considered to be a gold standard.”—[Official Report, Public Petitions Committee, 28 September 2017; c 4.]

Scotland had an opportunity to show global leadership on mesh. Like other members, I am extremely dismayed that the final report did not reflect that. We missed the opportunity to lead and we let down mesh survivors in the process.

The Public Petitions Committee has reflected that Professor Alison Britton’s report on the independent review will focus on the process that was followed and will not revisit the findings and recommendations of the report. In Dr Agur’s view, recommending that transvaginal mesh procedures must not be offered routinely does not give sufficient clarity. I, too, believe that the findings of the report must also be revisited.

It has been well reported that draft guidance from NICE will acknowledge the “serious and well-recognised” concerns about transvaginal mesh and recommend that it is not used, or is used only in the context of research. I hope that the cabinet secretary will provide clarity on the Scottish Government’s position on NICE’s advice and will say whether advice for clinicians in Scotland will follow it, given the challenges that the Government’s independent review faced. Will the work of the new oversight group change to reflect any updated advice?

In March, when the cabinet secretary made her statement on the review, she stressed that only the Medicines and Healthcare Products Regulatory Agency has the power to ban the use of mesh implants. However, the forthcoming NICE guidance is clearly another way to restrict the practice of the surgery. Why did health authorities in Scotland not take a similarly protective approach?

Ultimately, I agree with Elaine Holmes and Olive McIlroy that procurement is a matter for the Scottish NHS and the Scottish Parliament and that the fact that it is a UK-wide body that decides whether medical products are safe does not mean that the Scottish NHS should buy everything on offer. Alex Neil has made clear to the Public Petitions Committee his concerns about the MHRA’s independence and effectiveness as a body protecting public health, and I agree. Complete transparency regarding vested interests must be the norm.

Work to improve reporting of adverse incidents related to medical devices is more urgent than ever and the case for imposing a real suspension of all transvaginal mesh procedures is stronger than ever. I urge the cabinet secretary to open up the final report of the Scottish review of mesh surgery to public consultation. We must learn from the mesh survivors and ensure that they realise that we hear their voice. We must leave no stone unturned in delivering justice for them and making sure that not one more life is affected by those implants. We hear their voice.

16:18  

Alex Cole-Hamilton (Edinburgh Western) (LD)

I am grateful to the Public Petitions Committee for securing time for the Parliament to address something that for every one of the hundreds upon hundreds of women who are mesh survivors in this country is nothing short of a public health disaster. I am proud to add my voice to some incredible and passionate speeches that we have heard.

I put on record my thanks to Neil Findlay for arranging the visit that Alison Johnstone has just described during which members met mesh survivors, many of whom were in wheelchairs and all of whom were in abject pain. The experience prompted me to hold a member’s business debate just two weeks ago on the need for a national continence strategy, given that, although 80 per cent of cases of incontinence can be alleviated with appropriate physiotherapy, all too many cases have led to the insertion of potentially devastating implants and devices that, were they pharmaceutical products, might never have even made it out of the trial phase.

I was contacted at the weekend by a constituent of mine called Cathy, who has given me permission to share her story with members.

In 2010, after suffering very mild issues with incontinence, Cathy was referred by her physiotherapist to a consultant, who suggested that she could undergo a marvellous new procedure. Somewhat bewildered, Cathy was asked to sign a consent form then and there. She said that it felt as though she was entering a clinical trial, although it was never spelled out to her quite like that. In fact, nothing was properly spelled out to her. If those fully grown women had been given the facts about what was going to happen to them, they might all have made different decisions. Despite being booked in for the more invasive transobturator tension-free vaginal implant, which is secured via spikes through the obturator muscle, Cathy received very little information other than that the procedure would cure her incontinence.

When Cathy woke after surgery, she could not move. The nerve damage that she had sustained to her obturator muscles radiated pain throughout her abdomen, legs and back. Her condition was so bad that, when she was discharged, she would not allow her son to travel at more than 30mph along the bypass. With no let-up in the pain, she tried to call the hospital from three days after being discharged and throughout the following week, but never received a call back from nursing staff or doctors. To add insult to injury, and in the cruellest twist of irony, her incontinence worsened for a time.

When Cathy visited her doctor, she was told that the pain might be related to the fact that she had stopped smoking at the time of her operation, and that she should try cutting fat out of her diet as a means of helping, but at no point did any medical professional suggest that there could be a physical problem with the mesh implant.

All told, Cathy went a full five years of trying to cope with abject pain before the cause was identified as the mesh implant. A routine check-up with her gynaecologist revealed that the tape was in too tight on the right-hand side and, as such, was constantly tearing at her obturator muscle. On seeking the advice of her surgeon, she received the devastating news that, because her tissue had grown around the implant, it could not be removed without further significant nerve damage. Had someone taken her call at the hospital in the days after her operation, a reversal or correction could have been performed. Imagine her horror at receiving that news, and also consider that she, like several others, had been told at the time of the surgery that the mesh plastic would simply melt away over time.

Once the cause of Cathy’s pain was identified as the physical obstruction inside her, she was heavily medicated with gabapentin. The drug had a soporific effect on her, which forced her to retire from the job that she loved way before she had planned to.

Cathy’s implant has had a significant impact on her mobility, her intimacy with her partner and her mental health. The mesh implant has devastated her quality of life and she is left with the Hobson’s choice of making do or having it removed with potentially far greater nerve damage and resultant pain. As I stated at the start of my speech, she felt rushed into the procedure, she was not clear about her options and, given the lack of understanding on the part of the clinicians who tended to her about possible side effects, she had the impression that she was part of a clinical trial.

Cathy is far from alone in feeling like that. Yesterday, I was contacted by a constituent called Tress who underwent a similar procedure. In her case, it was for a prolapse that resulted from a hernia in 2010. In order to send a message to members this afternoon, she has allowed me to read out a brief passage from the message that she sent me. She wrote:

“I feel it was an unnecessary operation but was bullied into having it, being told it was my last option. I was not informed of the risks. My life has changed. I suffer from chronic pain, as well as recurring infections, and I have to have antibiotics in the house at all times. I have been for investigations but was told my mesh was safe. No, it’s not safe; no mesh is safe, and we have lost several lovely ladies through having a mesh fitted.”

It is the human cost, as expressed in Tress’s words, that underscores that the situation is a public health disaster. At the end of October, the world lost Christina Lynn Brajcic, a formidable Canadian mesh campaigner, to sepsis from the infections that she had sustained relating to her mesh implant. She is part of a death toll that is increasing. Because of that, I add my voice to those who are calling for the petition to be kept open, for a full and frank assessment of the final review—we can see that there is cross-party consensus that it is unsafe—and for a policy response that protects patients from the horrors of mesh implant side effects in absolute terms with a full and continuing moratorium.

16:24  

David Torrance (Kirkcaldy) (SNP)

I, too, put on record my thanks to the Public Petitions Committee and to the mesh survivors group. During my time on the committee, in the previous parliamentary session, we heard evidence from a range of women as well as from medical organisations, charities and fellow MSPs. We listened to the opinions and evidence of several patients. We were asked to reconsider the best mechanism for compiling research evidence, and we analysed statistics as well as both patient and expert views to find out more about the nature and scope of the problem. We also listened to women who had undergone the surgery.

The committee travelled to Brussels to give evidence to one of the European Commission’s science committees and to the European Parliament’s Committee on Petitions to update them on the work that we had carried out on mesh implants. The committee also listened to clinical experts locally and around the UK, while the Scottish Public Health Network, alongside the information services division of NHS National Services Scotland, provided us with an objective review of the research literature. I can, however, say with confidence that the evidence that the committee took from the women was the most emotional evidence that we heard in my time as the deputy convener. Some of them have experienced severe and constant abdominal pain, infections and bleeding, and some have been left unable to have sexual intercourse while others have been left disabled as a result of the procedure.

Early last week, a well-known Canadian campaigner against vaginal mesh procedures became the first woman to die in what has become known as the vaginal mesh scandal. I was deeply saddened to hear that she had had only minor complications, which a simple procedure could have prevented, but she became immune to the antibiotics that she was given as a result of major complications of the procedure. Her death came just a week after NICE’s draft report recommended banning vaginal mesh as a routine procedure for prolapse, claiming that the implants should be used only for research and not in routine operations.

More than 400 women in Scotland have gone through the procedure since the health secretary called for the use of the implants to be suspended, in June 2014. Although thousands of women have had the implants over the past 20 years, many of them have experienced agonising and life-changing implications. Three years after the suspension of their use, fierce debate still continues as to whether the devices should be banned completely. However, the MHRA has found no evidence to indicate that mesh implants are unsafe. In a report that was published in 2014, the agency claimed that, although a small number of women had been affected by adverse implications, the benefit of tape and mesh implants outweighed the risks and could help in dealing with upsetting conditions. Nevertheless, although the MHRA announced that only 12 women UK-wide had reported cases to them, more than 3,000 women have undergone repeated operations in an attempt to resolve problems and complications from the surgery.

The debate over the past few years has shown us that there is a serious lack of information in circulation in Scotland regarding the surgery. In line with the NICE recommendations, patients should be provided with the information that they need to make informed choices. It is outrageous that some of the women who had experienced problems told us that they were not aware that the implants were permanent. Informed consent should be introduced fully and uniformly throughout Scotland’s health boards, and I will encourage the MHRA to reclassify TVM devices to heightened alert status to reflect on-going concerns not just in Scotland but worldwide.

Informed consent is a fundamental principle underlying all healthcare interventions, and it is extremely important that women know the ins and outs of the procedure before agreeing to it. What is most appalling, however, is that some of the women who experienced adverse effects felt that they were not believed, which added to their distress and increased the period of time before any remedial intervention could take place. Women felt that their voices had not been heard as they raised concerns about the side effects that a number of them had suffered. Many of them eventually felt that the only way to bring the matter to the attention of the Scottish Parliament was to lodge a petition bringing the issue to the attention of the Public Petitions Committee.

There is, without doubt, a serious possibility that the implants will continue to have a profound impact on the lives of many Scottish women, so I am pleased that there is general agreement on the conclusions of the current Public Petitions Committee. We need to revise and enhance governance around the launch of both new medical procedures and new approaches, give women more opportunities to report any adverse effects should they arise and re-evaluate how women are assessed and treated.

The lack of understanding of the effects of the implants means that the Government and key stakeholders must ensure that the guidance that is given to the NHS and clinicians is based on the most robust, up-to-date and accurate evidence. Similarly, good information is essential to good patient care. The women need much more than we are currently providing for them, including adequate time for discussion and reflection, and we must make them aware of patient choice and involve them in shared decision making supported by robust clinical governance.

Ultimately, we need to see the recommendations, as well as the evidence from women who have been affected, reflected in the patient safety and clinical governance strands of the NHS. Although the debate will continue, in order to progress further the Government needs to co-operate with key stakeholders to address information gaps and ensure that the available information is used as effectively as possible to support safe and effective care.

The Scottish Parliament must act under the restraint that it lacks the authority to withdraw the product, but our job as policy makers is to challenge the status quo and represent those women so that their voices are not drowned out. I ask my fellow members to support the continued suspension of TVM implants and to expose some of the false information that is being circulated about this potentially life-altering procedure.

16:30  

Michelle Ballantyne (South Scotland) (Con)

I echo the sentiments of gratitude towards Elaine Holmes and Olive McIlroy for lodging the petition and for their unyielding courage in sharing their stories with us and the world. I am relatively new to the petition—indeed, I am new to the Public Petitions Committee—but, after hearing of their strength and courage through adversity and their will to stand up and speak out on behalf of mesh survivors across the country, I empathise fully with their resentment and dismay at the review process, not least because I have undergone a mesh procedure myself.

It is important that the women are heard today, because their own words—shaped through pain, angst and frustration—should resonate with us all as human beings and as parliamentarians. They said that their voices had been “drowned out and stifled”. They said that they had endured “adversity and pressure” for “almost three years” as patient representatives on the review group. They said that they had felt “physically sick” upon reading the final report.

Those words encapsulate what we heard at the committee: that the report’s recommendations will not succeed in “reducing harm to patients” from the procedure. Those are not my words but the words of Dr Wael Agur, in his evidence to the committee. He told us, in no uncertain terms, what mesh can do. He spoke of mesh tape procedures causing “chronic pain”, and he expounded on the devastating problems that that can cause for intimacy in a relationship.

Dr Agur has performed mesh procedures—many of them. He speaks from a place of experience and expertise. He is quoted as telling of his “incredible pride” when he joined the review group to protect women in the future. That pride was short lived and supplanted by dejection, however. He now says that Scotland failed to live up to expectations. Since NICE has recommended banning the use of vaginal mesh operations to treat pelvic organ prolapse in England, the powerful words of Dr Agur take on a new profundity.

Of course, hindsight is a wonderful thing. We must remember that the procedure was, at first, whole-heartedly embraced by the profession and by patients as a simple, quick and life-changing solution to really troubling medical problems. It would be wrong to direct all the blame at the surgeons and specialists, such as Dr Agur, who performed the procedures in the expectation of improving their patients’ quality of life.

However, it has become very clear that procedural and regulatory deficiencies have been abundant. It has been acknowledged at the committee that there was no robust framework for ensuring fully informed consent. Indeed, even when the adverse consequences of mesh entered broader medical perception, heads remained firmly buried in the sand. Unfortunately, as my colleague Jackson Carlaw has highlighted, the whitewash of the report indicates that some heads are still there.

Survivors, professionals, experts and politicians are speaking with one voice. With that voice, we ask: did the MHRA have an undue influence in the arrangement of the report? Why was chapter 6 deleted from the final report? Why is the report engineered in such a way as to exhibit the benefits of mesh for incontinence while it obfuscates the potential for mesh erosion?

Damage to reputation does not justify it. A loss of funding from manufacturers does not justify it. Fear of litigation does not justify it. The report does not, should not and cannot justify lifting the suspension of polypropylene transvaginal mesh operations. When we make decisions on the issue, we should be able to look Elaine Holmes, Olive McIlroy and all survivors in the eye and say, honestly and transparently, that this will protect women from the pain that they endure—that this is the right way forward.

I do not believe that the cabinet secretary can do that today on the basis of the report. No amount of whitewash can conceal the facts. At a time when Australia and New Zealand are banning the procedure, legal actions are taking place all over the globe and acclaimed academics are describing the procedure as a “catastrophe”, one must question why the Scottish Government is dragging its feet.

The Scottish Government must set aside obstinacy in favour of engagement. I urge it to act decisively and ban mesh before it ruins more lives. [Applause.]

The Deputy Presiding Officer (Christine Grahame)

I politely remind people in the public gallery that it is not appropriate to clap. I understand why you are doing it, but it is not appropriate when the Parliament is meeting.

16:35  

Willie Coffey (Kilmarnock and Irvine Valley) (SNP)

Like many members who have spoken in the debate, I was made aware of the issue when constituents made representations to me. I heard their experiences at first hand, in my local surgeries.

I also sat in on a meeting of the Public Petitions Committee that was attended by a number of women who are affected by mesh implants, and who offered their time that day to provide MSPs with more information about the conditions that they endure in their daily lives as a result of undergoing the procedure. Some of their evidence was pretty harrowing, and I have to say that in my 10 years as a member of this Parliament I have not come across many cases like theirs.

The issues that the women face are very challenging. I would not pretend to understand all the medical complexities that are involved, but I hope that the debate at least gives all the affected women hope that their concerns are being heard and acted upon.

The review that the Scottish Government carried out, notwithstanding the disagreement about what was and was not included in the final report, at least went some way towards meeting the petitioners’ initial demands—the suspension of mesh procedures, mandatory reporting of all adverse events, the introduction of fully informed consent and, of course, the establishment of a review.

Health boards must put in place further safeguards before the procedure is reintroduced. As we know, and as members have said, in relation to pelvic organ prolapse the current evidence does not indicate any additional benefit from the use of mesh, and the procedure is not to be offered routinely.

Some of the review’s recommendations could reasonably have been put in place at the outset of the process. In particular, I am thinking of the recommendations on the provision of information, consent and mandatory reporting of adverse events. Why on earth would such an approach not be routine for a procedure in relation to which there are known risks? That is a bit of a mystery to me and to some of the women to whom I have spoken.

I had a look at the report, “A summary of the evidence on the benefits and risks of vaginal mesh implants”, which the MHRA produced in 2014. As members know, the MHRA is the sole UK body with the authority to withdraw products. It concluded:

“the benefits of the use of these devices outweigh the risks. This means there is no justification for the MHRA taking regulatory action to remove all of these devices from use in UK hospitals.”

I looked through the report to see how the MHRA had reached its conclusion, given the number of reported adverse incidents. It was interesting to learn that the MHRA had no data that showed how many mesh devices had been used. Instead, it was relying on sales figures to get an indication of that. Its data showed that between 2005 and 2013, in relation to SUI, there were 29 variants of devices, around 170,000 devices were sold in the UK and 291 adverse events were reported in England—the MHRA was using English data. In relation to POP, there were 25 variants, about 24,000 were sold in the UK and 110 adverse events were reported.

My point is that I could see no comment in the report on the statistical significance of the data and how it led the MHRA to conclude that the devices were safe. One adverse event is a matter of great regret. More than 400 such events were reported between 2005 and 2013, but no assessment was made of whether such a figure should be expected, statistically. I am still wondering how the MHRA was able to conclude that the devices were safe if it had not addressed the statistical probability of adverse events and dismissed the numbers. Perhaps we can attempt to clarify that point with the MHRA.

Members have already commented on the very sad news from Canada, where Chrissy Brajcic, who was treated for mild urinary incontinence with a mesh device, has recently died. That tragic news will undoubtedly mean that further demands will be made for such procedures to be reconsidered, and a more rigorous assessment of risks and the potential impact on women if those risks should materialise might well be given more prominence.

I said that it is impossible for us as laypeople to analyse and assess the evidence and impact of such mesh devices on the women who have come forward, but we have to listen, offer a forum in which concerns can be heard and expect those on whose professional judgment we rely to get this right. However, that cannot be the end of the story.

The number of women who have been affected adversely by the procedures in question might be small in relation to the total number of procedures that have been carried out, but when they occur, the impacts are particularly severe. Confidence is everything here. We must challenge our clinicians more on the risks that are involved, and we must restore confidence to the women involved before we proceed any further with such procedures.

The Deputy Presiding Officer

We move to the closing speeches.

16:41  

Anas Sarwar (Glasgow) (Lab)

I thank Johann Lamont and the Public Petitions Committee for securing this important debate and giving Parliament the opportunity to contribute to their deliberations.

Today, we have heard the best of our Parliament. We have heard from across the chamber a story of courage and emotion, strength, and dignity and determination in the face of the might of Scotland’s medical establishment. We have heard about the campaign that has been driven by a group of women who have been forced to struggle every step of the way against a medical establishment that has closed ranks to protect its own.

As every member who has spoken in the debate has done, I pay tribute to all the survivors, many of whom are in the public gallery, for their bravery, determination and courage in not taking no for an answer and pursuing the issue, not just to get justice for themselves but to protect patients in the future. I pay tribute to Elaine Holmes and all the other campaigners for their determination and the dignity with which they continue to campaign.

We have heard how medics closed ranks to protect their own reputation, how the medical establishment closed ranks to protect its relationships with medical companies and how the women affected have had to fight even to have their case heard.

I praise the work of my colleague Neil Findlay in steadfastly supporting the women affected and ruthlessly pursuing the truth. I also thank parliamentarians from other political parties—in particular, I thank Jackson Carlaw of the Scottish Conservatives and Alex Neil, who has continued his passionate and principled campaign on the cause since vacating the office of health secretary. I also thank the women throughout Scotland who continue to campaign. Without their campaigning, women in Scotland would still be having mesh implanted into their bodies, with consequences that are now well evidenced. If it were not for that campaigning spirit within and outwith the Parliament, we would not be debating the use of a procedure and a product that cause so many women to face a lifetime of chronic pain.

Fundamentally, the debate comes down to one word: confidence. The reality is that the survivors of the scandal do not have confidence in what has happened since the scandal. The review is compromised and we must accept that it is compromised, just as the MHRA is compromised and we must accept that it is compromised. I am sorry to say that Government action—I do not mean this to be a party-political point, and I will come on to explain how we can move forward—is also compromised. Unless we can give the survivors of the mesh scandal confidence that their Government, the institutions and the medical establishment are working in their favour and in the interests of justice—for them, rather than against what is in their interests—we will never be able to deliver justice for them. Confidence is crucial as we move forward. We must consider how we create a climate of confidence in the review process, the actions that come out of that review and what happens as regards the long-term use of the product.

There has been a cover-up. For medics to fail to declare a conflict of interests while serving on a review body is simply unacceptable. If parliamentarians were to take part in a committee process in which they had a conflict of interests, they would be hauled before the Standards, Procedures and Public Appointments Committee and rebuked by the Parliament. If it is not acceptable for parliamentarians to behave in that way, it is not acceptable for anybody in any profession to behave in that way while serving in a so-called independent review. The fact is that there is litigation over the use of a product and that the people who face that litigation are serving on the review body and failing to declare that interest. That is shameful behaviour that brings both the conduct of the review and that of medical professionals more widely into disrepute. We should call that out for what it is.

The evidence of the misuse of a product that is not fit for purpose is clear. In the US, manufacturers of the product have already paid out more than £1.5 billion in compensation. The survivors do not want to hear that the situation here might be a cover-up to try to protect money, whether from the public purse or from private companies, rather than a means of seeking justice. That is why what we do in the future will be so important.

The fact that NICE has banned the use of mesh operations in England speaks for itself. The fact that the product is banned in Australia and New Zealand also speaks volumes. The use of the product was wrong, with lifelong consequences. Today, we have an opportunity to put that right. More than 100 members of the Scottish Parliament have already put their names to a call for an honest and transparent review—not one that has been compromised by the actions of the medical establishment, but one that has process at its forefront and which is not tainted by a cover-up. We cannot allow the Parliament to look as though it is part of a cover-up, which is why we need to hear a commitment from the cabinet secretary that there will be a judge-led inquiry to bring this tragic and murky scandal into the full light of public scrutiny. There must be a review that will give women the chance to be listened to and lead to action being taken against those who are culpable. Nothing less than a judge-led review will suffice.

I have some specific and direct questions for the cabinet secretary. I say this in all sincerity: given the way in which the debate today has been conducted, we have an opportunity to bring together all our parties—Opposition and Government—to get to the bottom of the mesh scandal and give justice to people who have been affected by it. Following the debate, the cabinet secretary has an opportunity to unite our Parliament in that process.

I repeat what Alex Neil said about his not having been told

“the truth, the whole truth and nothing but the truth”.

For a former cabinet secretary to say that he did not believe that he had got that from his most senior officials when he was in office as a member of the Scottish Government and this Parliament is absolutely damning, and we should not take it lightly. We have to know whether those people are still giving the same advice to the present cabinet secretary and, if they are, how we can expose that and make sure that the position changes.

We must make sure that, when we have a moratorium, it means just that, and that we review mesh procedures not just in women, but, as we heard from Alex Neil, in men, who also suffer complications when they undergo those procedures. We must consider how a genuinely independent review might work: whether we should open up the report for public comment before final publication; whether the use of mesh products should be indefinitely suspended; whether we should use the Parliament’s procurement powers to end the purchase of the product; and whether we should settle litigation cases quickly and stop deliberate stalling by companies. Anything less than that will be a failure and a betrayal of the women who are sitting in the public gallery. Anything less will be a betrayal of the best of this Parliament and the best of this country.

I hope that, by working together across the Parliament and across all political parties, we can, once and for all, give justice to survivors of the mesh scandal in Scotland and ensure that it never happens again.

16:49  

Miles Briggs (Lothian) (Con)

I am pleased to close for the Conservatives. The debate has been a useful and thoughtful discussion. Like others, I pay tribute to current and former members of the Parliament’s Public Petitions Committee for their consistent work on this subject over a number of years. This is another good example of the important role that the Public Petitions Committee plays in the political process in modern Scotland. Like others, I commend the petitioners Elaine Holmes and Olive McIlroy, who have done so much to speak up for those who have suffered as a result of receiving mesh implants and tape procedures. I welcome all those in the public gallery who have campaigned so hard. I hope that, today, Parliament has given them a voice and done them justice.

A number of members have spoken in detail about the horrendous health impacts that some women have experienced as a result of mesh implants and tapes for prolapses and stress incontinence. As a newly elected MSP, I, along with many MSPs, first met the mesh campaigners in Parliament following the publication of the draft report of the review group. Those women had, in good faith, desperately sought answers, and I have to say how angry I felt going home that the review group that they had hoped would challenge, and seek answers and the clarity that they had been looking for, had been compromised, and that a whitewash of a report that helped no one had finally been published. Those women have been badly let down. The whole chamber will have sympathy for them, but they do not want sympathy—they want answers and action.

Jackson Carlaw expressed very clearly the frustration and anger of mesh campaigners over the past few years. It took a great deal of pressure before the then Cabinet Secretary for Health and Wellbeing, Alex Neil, announced an independent review in June 2014. At the time, the health secretary also announced a suspension of the use of mesh implants, but we know that half of Scotland’s health boards continued to use the devices, with more than 400 procedures having been carried out despite the ban.

My colleagues Brian Whittle and Michelle Ballantyne raised real concerns about the role and impact of ministerial directives on NHS health boards in Scotland. Monica Lennon asked why those directives were blatantly ignored. Why have the health secretary and the Scottish Government been totally disregarded by some Scottish health boards when they have issued such directives? All of us in this chamber will want answers to those questions.

Since the ban, and despite the Scottish Government’s position, continuing concerns about the safety of mesh tape implants and the fact that the NHS in Scotland faces several hundred damages claims from women who have been affected, hundreds of women have received mesh tape implants. We heard three great speeches today from Jackson Carlaw, Neil Findlay and Alex Neil, who have been involved from the outset. All three demonstrated that the contents of the report have been compromised and diminished. I very much endorse Alex Neil’s call for any future guidelines to involve patients and take account of their experiences. The fact that the cabinet secretary has had to appoint Professor Alison Britton of Glasgow Caledonian University to conduct a report into how the inquiry was undertaken only highlights the extent of the concerns about the inquiry.

In recent weeks, we have had a major new development with the news that NICE is set to recommend that mesh operations to treat organ prolapse should be banned. It is understood that the draft guidelines from NICE say that the implants should be used only for research and not routine operations, and that

“evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”.

NICE’s move will mirror a similar decision by equivalent bodies in Australia and New Zealand and comes at a time when more very worrying academic evidence has been produced about mesh erosion rates. NICE’s guidance should act as a further wake-up call to the Scottish Government and should prompt it to take decisive action to ensure that there is no interruption to the current suspension of the use of mesh, in order to prevent any more women or men being harmed.

Patients in Scotland deserve better than the response to this major issue that has been provided to date. I agree with Jackson Carlaw and Alex Neil that the Scottish Government should act now to convene an international summit here at Holyrood to allow Scotland to seek answers for families and, once again, gain the political initiative.

I hope that this debate will help to push ministers to address in full the genuine and legitimate concerns of mesh campaigners, and to ensure that the safety of patients is always the overriding priority when the use of such invasive surgery and new technology is being considered.

On 7 November, the First Minister apologised on behalf of the Scottish Government to gay men convicted of now-abolished sexual offences. That was a welcome moment in this Parliament’s history, in which we saw parties from across the chamber come together as an injustice was addressed and acknowledged and saw the Scottish Government take action.

I believe that the Scottish Government and this Parliament need to make amends to those women and their families across Scotland who have so clearly been failed. There is a lot of work to do to regain the confidence of those affected by the mesh scandal, including the survivors. It is time for Scottish Government ministers to act and make Scotland the leading beacon once again, for all of them.

16:55  

Shona Robison

I thank members for their speeches in this afternoon’s important debate. I will try to respond to as many as possible of the points that have been made. Like other members, I hope that we can work together on this important issue.

First, I will touch on the role of the Medicines and Healthcare Products Regulatory Agency. Many members raised concerns about it and referred to its key role as the only organisation that can ban a procedure or product. To highlight what I said in my opening remarks, it is important that the MHRA takes account of international evidence that is emerging and the action that is being taken in other places, such as the Australian Therapeutic Goods Administration. That is why the chief medical officer has written to the MHRA asking what its response is to the action taken by the Australian TGA to remove mesh for pelvic organ prolapse and single incision mini-slings. That does not apply to stress urinary incontinence, I have to add, so the MHRA must be very clear what the TGA has done—its focus is on removing mesh for pelvic organ prolapse and single incision mini-slings. We await the response of the MHRA on that issue.

John Scott

Will the member take an intervention?

Shona Robison

Yes—I promised that I would let John Scott in.

John Scott

Thank you. Given the alleged conflict of interest of the MHRA and the source of some of its funding, does the cabinet secretary think that it is time for a review of its corporate governance arrangements and is that something that she might consider pursuing?

Shona Robison

I am happy to pursue that. We have raised a number of concerns about the role of the MHRA, not least from points made by members in this chamber. We have regularly put those to the MHRA and the Department of Health, which has oversight of the MHRA.

Many issues have been raised about the independent review process and I will come on to one specific issue in a moment. However, I think that we should allow Professor Britton to carry out her review, which will look at all of the issues raised during this debate, not least the issue that was raised by Alex Neil—and by Neil Findlay, I think—about how interests are disclosed and registered. It is important, not just for the present independent review, but for future reviews on any issue, that there is full disclosure of interests and that they are registered. Professor Britton will be looking at that issue along with the many other issues that have been raised about the independent review process.

Neil Findlay

Given what the cabinet secretary has just said, which is very important, is it now her view that the review was compromised by that issue?

Shona Robison

I certainly understand the concerns about the review process; I would not have asked Professor Britton to look at the independent review if I did not have concerns. However, that fact does not detract from the important recommendations that the review has made. With regard to POP, it has effectively restricted the procedure to exceptional cases only, and I will come on to NICE in a minute, in relation to taking that even further. We need to recognise, as other members have, that some of the recommendations are very important.

Members have asked how procedures could still have gone ahead in the light of the moratorium on mesh procedures. As I have said before in this chamber, in a small number of cases where a woman who had been fully informed of the risks still wanted to go ahead with the procedure, as they were experiencing very distressing symptoms, and a clinical judgment to proceed was reached in a fully informed discussion between the clinician and the patient, nothing could be done to stop it from going ahead, because the procedure is not banned. I understand members’ frustration about that, but those were clinical decisions and the procedure is not banned. However, it is very important that the restrictions that are placed on the use of mesh are fully and consistently implemented. I will say a bit more about that in a second.

Johann Lamont

Will the cabinet secretary clarify what she understands a moratorium to be? What advice was she given in that regard? What did her predecessor expect a moratorium to be?

Shona Robison

I cannot speak for what Alex Neil wanted to happen, although I assume that it was the same as what I wanted: that the boards would suspend the procedures.

We were fully aware that the procedure is not banned. Therefore, if there was a clinician with a fully informed patient who wanted that procedure to go ahead, nothing could be done to prevent that. I have explained that a number of times in this chamber. It might be frustrating for members to hear that, but those are the facts.

The MHRA is the only organisation that can ban the procedure, and I have already said what we are doing to make sure that it is more fully informed.

Brian Whittle

Will the cabinet secretary take an intervention?

Shona Robison

Very briefly, because I have got other points to cover.

Brian Whittle

I recognise that the MHRA is the only organisation that can withdraw mesh devices. However, given that the NHS funds the operation and the cabinet secretary has the ability to take away that funding, she could stop the procedures from going ahead.

Shona Robison

I am not a clinician. I cannot make a judgment about withdrawing the funding for a procedure that is not banned. That would get us into very difficult territory. We have to be guided by the clinical advice. If the MHRA is going to look again at the issue, and I understand that it continues to look at the international evidence—

Neil Findlay

Will the cabinet secretary give way on that point?

Shona Robison

Not at the moment—I want to make progress.

The MRHA will look at the Australian and other evidence. I hope that it keeps the evidence under review. I would like the MRHA to reach a different conclusion but, so far, it has not done so.

Alison Johnstone asked a very important question about the NICE guidance. First of all, it is very important to understand that the NICE guidance on pelvic organ prolapse says that mesh procedures can be delivered for research purposes only.

NICE has been clear that it cannot ban mesh procedures; it has provided guidance. I must be very clear about that: NICE has been very clear in saying that it cannot ban the procedure. It provides guidance, and we will follow that guidance. The NHS in Scotland always follows NICE interventional guidance in the same way as would be the case in the rest of these islands—I hope that that reassures Alison Johnstone.

It is important to have further restriction beyond those that are in place for POP. The oversight group will incorporate that additional guidance into the guidance that it is developing.

Alex Neil made a number of important points, the most important of which was probably to ask how patients will be involved in the oversight group. I confirm that patients will absolutely be involved. I understand the trust issue that many of the women, not least Elaine Holmes and Olive McIlroy, have. It would be very hard, and perhaps unreasonable, to ask them to be involved in any other processes. Personally, I hope that they would consider being involved, because women who have had personal experience are exactly who we want to be involved in the oversight group, to take forward the issues and to develop leaflets for women so that they have the full information and can make fully informed decisions. I certainly hope that patients will be involved in the process, because it will make the procedures and the work of the oversight group very important and, perhaps, will help to build confidence in the material that will be put out in order to help ensure that patients are fully informed about any procedure that they undertake in this area.

I am sorry if I have not been able to respond to all members. If I have not been able to answer specific questions, I will write to members to make sure that they get the full information that I have not covered in my closing remarks.

The Deputy Presiding Officer

I call Angus MacDonald to close the debate for the Public Petitions Committee.

17:05  

Angus MacDonald (Falkirk East) (SNP)

Thank you, Presiding Officer. How long do I have for my speech?

The Deputy Presiding Officer

How long do you wish?

Angus MacDonald

Nine minutes?

The Deputy Presiding Officer

Nine minutes is absolutely fine by me. I might even give you 10 minutes.

Angus MacDonald

Perfect.

Alex Neil

You can take an hour.

Angus MacDonald

I am pleased to close the debate on behalf of the Public Petitions Committee. I thank members from across the chamber for their excellent individual contributions, which I will turn to in a short while.

As the convener said when she opened the debate, the petition was lodged during session 4. I have been a Public Petitions Committee member throughout consideration of the petition to date and, in that time, a wide range of evidence has been presented by the petitioners, the Scottish Government and other relevant parties. The strength of feeling and the emotions at meetings when the petitioners and fellow sufferers have given evidence have been tangible. We have taken substantial amounts of evidence, including from a lawyer who represented mesh-damaged women who were involved in litigation in America, and from the Medicines and Healthcare products Regulatory Agency, which is responsible for licensing medical devices in the UK.

It has been made clear throughout the debate that there is no doubt about the seriousness of the issues that were raised by the petition, or about the physical and emotional impacts of the adverse events that have arisen from mesh procedures. It is clear that it was partly, if not wholly, thanks to the petition that the Scottish Government asked health boards to suspend use of mesh in 2014 due to clinical concerns. That clearly reflected the seriousness that the Scottish Government attached to the issue. Alex Neil is to be commended for the action that he took as health secretary to introduce the suspension and the review until all the necessary procedures, approvals and restrictions were in place.

The petition asked for several things, including suspension of all mesh procedures, the establishment of an independent review, mandatory reporting of adverse events and the introduction of fully informed consent. Much of that has been, or will be, achieved as a result of the petition, so I join the convener and other members in paying tribute to the work of the petitioners on putting the issue in the spotlight.

Valid and salient points were made by Jackson Carlaw in a strong speech. He is a former member of the Public Petitions Committee: he asked searching questions during our evidence sessions and raised a number of those points this afternoon—not least of which was the woeful performance of the MHRA’s representatives in giving evidence.

Neil Findlay has doggedly pursued the issue in committee meetings, and has worked on the issue outwith the committee system. He has made a significant impact in the campaign and continues to raise concerns regarding how the issue has been handled

Alex Neil made a heartfelt and candid contribution to the debate, including his call to review the contents of the initial review. He has called—in September in the committee and today in the chamber—for an international mesh summit to address the growing global crisis. There is much merit in that suggestion; it may be beyond the capacity of the Public Petitions Committee to hold such a summit, but I am sure that we can consider including the suggestion in the forthcoming committee report, which I hope will be completed in the not-too-distant future.

Rona Mackay detailed the review recommendations and, as other members did, rightly questioned the role of the MHRA. Monica Lennon spoke of the rage that is felt by mesh survivors; she referred to the issue as “a national scandal” and “an outrage” and called for a judge-led review. Alison Johnstone highlighted the lack of informed consent, and concentrated on the evidence that was given to the committee by Dr Agur.

David Torrance highlighted the successful visit to Brussels by the Public Petitions Committee, under the convenership of David Stewart, on which we made sure that the issue was well and truly on the radar of the European Commission.

Michelle Ballantyne is a new member of the committee who has made a strong contribution to the committee’s work. She highlighted Dr Agur’s evidence, during which he detailed the adverse impacts of mesh implants.

Willie Coffey spoke about the harrowing evidence that was given when he was present, and Brian Whittle, among many salient points, questioned the failure to have the moratorium fully implemented. Alex Cole-Hamilton went into some detail about the situation that his constituent has endured. We have heard excellent speeches in the chamber today, so I am sorry that I cannot dwell on many of the other points that were raised.

In his closing speech, Anas Sarwar spoke of the medical establishment closing ranks and about conflicts of interests, which we hope to get to the bottom of through Professor Britton’s review of the review, and Miles Briggs highlighted in his closing speech the disregarding of directives by some Scottish health boards and the current situation regarding NICE guidance.

Although there has been a focus throughout on the issue in the Scottish context, there is little doubt that the issues that we have been considering extend far beyond our own borders; indeed, it has been referred to as “a global scandal”. There was a sense, back in 2014, when the then cabinet secretary, Alex Neil, announced the independent review and moratorium, that Scotland was taking the lead on what was considered to be a matter of significance around the world. As work in Scotland has continued, there have been developments in other countries, and it may now be the case that some other countries are seen as leading the way, which is unfortunate, given where we were. I will leave to others the judgment about who is leading the way.

I would like to comment on some recent developments in other jurisdictions that have been mentioned this afternoon. Last week it was reported that, later this month, the National Institute for Health and Care Excellence will issue updated guidance on use of mesh. On that point, it is worth noting that the office of the chief medical officer has previously advised NHS boards and directors that the investigation and treatment of all patients should follow NICE guidelines which, although they are not mandatory in Scotland, are recommended as good practice. I hope that the cabinet secretary will provide an update to the committee on best practice across Scotland in the event that NICE updates its guidelines.

As recently as 28 November, Australia’s Therapeutic Goods Administration, which is the equivalent of the UK’s MHRA, announced that, with effect from 4 January 2018,

“transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation”

will be removed

“from the Australian Register of Therapeutic Goods”.

That decision was based on the TGA’s belief

“that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.”

It added:

“The TGA also considers that there is a lack of adequate scientific evidence before the TGA for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.”

I believe, thanks to information that has been received from the petitioners, that that is also the situation in New Zealand. For the Public Petitions Committee, the recent developments here and abroad will be something to reflect on as we consider our draft report.

I think that it is more than likely that we will also, in time, consider the findings of Professor Britton’s review of the review. I hope that it will be a robust review: it should report on the process and flaws of the first review, so that lessons can be learned for the future, including ensuring that patient representatives feel that they can fully participate—which was, sadly, not the case in the first review. Professor Britton’s review will consider the process of the independent review and will make recommendations for the conduct of similar reviews in the future. However, the professor will not re-examine the evidence that was considered by the initial independent review, and her conclusions will therefore have no bearing on the moratorium that was ordered in 2014 and which continues to this day. I understand that Professor Britton will soon begin consulting for her work. I hope that individuals who have been impacted by mesh feel able to respond to that consultation; in fact, I encourage them to do so.

In the meantime, the Public Petitions Committee will continue to welcome any contributions from members of the public who want to ensure that Parliament hears their voice. I am sure that I speak for all the committee’s members, if not for the whole Parliament, when I say that I look forward to working on the draft report and to ensuring that the petitioners and campaigners who have ensured that this dreadful set of circumstances is on the radar are given their voice and listened to. To paraphrase the convener’s remarks in her opening speech, this petition is far from closed.

The Deputy Presiding Officer

That concludes the debate on petition PE1517 on polypropylene mesh medical devices. It is time to move on to the next item of business. I suspend the meeting briefly to allow a change of seats for the next item, which will be an urgent question.

17:15 Meeting suspended.  17:16 On resuming—